NCT01721057 · OUTCOME
Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Week 12
What was measured
Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.
Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Groups in this outcome
Placebo
Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
Baricitinib 2 mg
Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
Baricitinib 4 mg
Baricitinib 4 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
| Group | Source count |
|---|---|
| Placebo | 221 |
| Baricitinib 2 mg | 223 |
| Baricitinib 4 mg | 222 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 4.7 | 2.2 | Not reported | Not reported | Not reported |
| Baricitinib 2 mg | 3.9 | 2.5 | Not reported | Not reported | Not reported |
| Baricitinib 4 mg | 3.8 | 2.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.2
- value
- 4.7
- group Id
- OG001
- spread
- 2.5
- value
- 3.9
- group Id
- OG002
- spread
- 2.2
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 221
- group Id
- OG001
- value
- 223
- group Id
- OG002
- value
- 222
- units
- Participants
- description
- Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.
- dispersion Type
- Standard Deviation
- groups
- description
- Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
- id
- OG000
- title
- Placebo
- description
- Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
- id
- OG001
- title
- Baricitinib 2 mg
- description
- Baricitinib 4 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
- id
- OG002
- title
- Baricitinib 4 mg
- param Type
- MEAN
- population Description
- mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
- reporting Status
- POSTED
- time Frame
- Week 12
- title
- Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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